Estabilidade de soluções de cloridrato de dobutamina em diferentes tempos e a influência do aquecimento e da luminosidade decorrentes da infusão no interior de incubadora e sob fototerapia

• Autor(a) principal: Domenicis, Tatiany Calegari de [UNIFESP]
• Data de Publicação: 2017
• Tipo de documento: Tese
• Idioma: por
• Título da fonte: Repositório Institucional da UNIFESP
• Texto Completo: https://sucupira.capes.gov.br/sucupira/public/consultas/coleta/trabalhoConclusao/viewTrabalhoConclusao.jsf?popup=true&id_trabalho=5070202; http://repositorio.unifesp.br/handle/11600/50475
• topic: Drug stability; Infusions; Intravenous; Dobutamine; Pediatric nursing; Neonatal nursing; Patient safety; Estabilidade de medicamentos; Infusões intravenosas; Enfermagem neonatal; Dobutamina; Enfermagem pediátrica; Segurança do paciente

Introduction: Critically ill children in intensive care unit often receive dobutamine hydrochloride in continuous infusion by central intravenous catheter. The environmental factors such as luminosity and temperature from this unit can compromise the drug stability. Objectives: Validating analytical methodology by High Performance Liquid Chromatography (HPLC) to determine the concentration and the dobutamine hydrochloride stability; analyzing the pH, the osmolality and the pure and diluted dobutamine hydrochloride in sodium chloride in 0,9% (NaCl 0,9%) concentration according to the exposure time under environment temperature/fluorescent lamps and high incubator temperature/phototherapy light influence. Methods: This is an experimental study developed at Universidade Federal de São Paulo. The developing analytical parameters were determined due to analytical methodology validation: selectivity, linearity, range, precision, accuracy, robustness and stability. The sample was composed by 60 pure dobutamine hydrochloride aliquots and 60 from the diluted drug (16 milliliters – mL of drug in 32 mL of NaCl 0,9%) with the syringe of 20,0 mL with disposable hypodermic needle 30,0 x 0,8 millimeters use, kept in graduated burettes, which was exposed to environmental conditions with fluorescent lamps/mean temperature of 23,1ºC±1,3 and phototherapy luminosity/high incubator temperature with the mean temperature of 39,8ºC±0,7. The pH analysis, osmolality and concentration were carried out immediately (T0), 2 (T2), 4 (T4), 24 (T24), 48 (T48) and 72 (T72) hours after preparing, by the digital benchtop pHmeter, osmometer and HPLC. The results were analyzed according to the mean (±standard deviation) and median (Interquartile range), tests were applied Student’s t-test, Mann-Whitney, ANOVA, Kruskal-Wallis and the significance level of p≤0,05 was established. Results: The developed method of dobutamine hydrochloride separation by HPLC has shown being selective, without interference of mobile phase, diluent and other compounds; linear in the range of 80% to 120% of the theorical concentration test; precise repeatability and intermediate precision; exact to the concentrations 0,40, 0,50 and 0,60 milligrams per milliliter (mg/mL); robust to the changes caused in the column temperature, composition and the flow rate of mobile phase; stable during 24 hours after the prepared sample. The pH has shown significant reduction as the pure as the diluted dobutamine hydrochloride and the osmolality variations weren’t significant in 72 hours exposure to environmental conditions and incubator/phototherapy. The concentration has kept stable to the pure and to the diluted drug from T0 until T72 (p=0,68 and p=0,25, respectively) in environmental condition. The pure drug concentration has shown slight increase (p=0,68) and the diluted drug has occurred statistically significant reduction during the exposure period (T0=96,90%±1,39 to T72=92,03%±1,47; p=0,0004) under high incubator temperature level and phototherapy, however, keeping the solution stability due to the changes has been lower to 10%. Conclusions: The chromatography method to analyze the dobutamine hydrochloride concentration was considered validated. The pure and diluted dobutamine hydrochloride has kept acid, hypotonic and chemical stable in 72 hours exposure to the environment and incubator/phototherapy.